U.S. patent application number 12/033935 was filed with the patent office on 2008-08-28 for method and apparatus for occluding an anatomical structure.
Invention is credited to Eric E. Bielefeld, Greg R. Furnish, Jason I. Glithero, Michael W. Goldenbogen, Todd A. Hall, Livyn O. Okorocha, Stephen C. Robinson, James G. Tappel, Chadd R. Tyler.
Application Number | 20080208324 12/033935 |
Document ID | / |
Family ID | 39716816 |
Filed Date | 2008-08-28 |
United States Patent
Application |
20080208324 |
Kind Code |
A1 |
Glithero; Jason I. ; et
al. |
August 28, 2008 |
METHOD AND APPARATUS FOR OCCLUDING AN ANATOMICAL STRUCTURE
Abstract
Methods and apparatus for occluding an anatomical structure
including a device having at least first and second clamp portions
adapted to cooperate to move from an open position adjacent an
anatomical structure to a closed position engaging and occluding
the anatomical structure. A system for delivery of a fluid to
affect occlusion of an anatomical structure is provided, as well as
an applicator for deploying occlusion devices having different
sizes.
Inventors: |
Glithero; Jason I.; (Mason,
OH) ; Okorocha; Livyn O.; (Cincinnati, OH) ;
Tappel; James G.; (Cincinnati, OH) ; Bielefeld; Eric
E.; (New Albany, IN) ; Goldenbogen; Michael W.;
(Floyd Knobs, IN) ; Tyler; Chadd R.; (Sellersburg,
IN) ; Hall; Todd A.; (Goshen, KY) ; Robinson;
Stephen C.; (Milford, OH) ; Furnish; Greg R.;
(Louisville, KY) |
Correspondence
Address: |
COOK, ALEX, MCFARRON, MANZO, CUMMINGS & MEHLER LTD
SUITE 2850, 200 WEST ADAMS STREET
CHICAGO
IL
60606
US
|
Family ID: |
39716816 |
Appl. No.: |
12/033935 |
Filed: |
February 20, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60891298 |
Feb 23, 2007 |
|
|
|
Current U.S.
Class: |
623/1.36 ;
606/151; 623/1.3 |
Current CPC
Class: |
A61B 17/12136 20130101;
A61B 17/12186 20130101; A61B 17/122 20130101; A61B 17/00491
20130101; A61B 2017/0641 20130101; A61B 17/1227 20130101; A61B
17/1327 20130101; A61B 17/0643 20130101; A61B 17/12122 20130101;
A61B 2017/00243 20130101 |
Class at
Publication: |
623/1.36 ;
606/151; 623/1.3 |
International
Class: |
A61F 2/06 20060101
A61F002/06; A61B 17/08 20060101 A61B017/08 |
Claims
1. A device for occluding an anatomical structure comprising: at
least first and second clamp portions adapted to cooperate to move
from an open position that permits placement of the device adjacent
an anatomical structure to a closed position that engages and
occludes the anatomical structure.
2. The device of claim 1, wherein the at least first and second
clamp portions comprise first and second beams.
3. The device of claim 1, wherein the at least first and second
clamp portions comprise a beam and a flexible member.
4. The device of claim 1, wherein the at least first and second
clamp portions are connected in a manner that forms a loop.
5. The device of claim 1, wherein the at least first and second
portions are hingedly connected.
6. The device of claim 1, further comprising a fabric covering that
covers at least one of the at least first and second clamp
portions.
7. The device of claim 1, wherein at least one of the at least
first and second clamp portions includes barbs adapted to pierce
tissue.
8. A system for occluding an anatomical structure comprising: a
fluid expulsion portion, a fluid transmitting portion, a fluid
adapted to be expelled from the fluid expulsion portion to provide
occlusion of an anatomical structure.
9. The system of claim 8, wherein the fluid is a liquid
substance.
10. The system of claim 8, wherein the fluid transmitting portion
transmits the fluid to a position within the anatomical
structure.
11. The system of claim 8, wherein the fluid transmitting portion
transmits the fluid to a fluid retention portion that engages the
exterior of the anatomical structure and the fluid is a gaseous
substance.
12. An applicator for deploying an occlusion device, the applicator
comprising: a handle, arms connected to the handle and being
adapted to engage an occlusion device, the arms having multiple
portions that permit adjustment to engage occlusion devices having
different sizes.
13. The system of claim 13, wherein the arms have telescoping
portions.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application Ser. No. 60/891,298, filed Feb. 23, 2007, the contents
of which are incorporated herein by reference.
BACKGROUND
[0002] Embodiments of the present invention relate to devices and
methods that may be used to occlude a hollow anatomical structure.
Examples of occlusion devices and associated methods are described
in U.S. application Ser. No. 10/853,928, filed on May 26, 2004,
U.S. Application Ser. No. 60/699,309 filed on Jul. 14, 2005; and
International Application Serial No. PCT/US2006/027553, published
as WO 2007/009099, and filed on Jul. 14, 2006, each of which are
incorporated by reference herein. For instance, it may be desirable
to occlude an anatomical structure such as, for example, the left
atrial appendage (LAA), in a manner sufficient to prevent the entry
of blood therein. It will be appreciated that blood may otherwise
tend to clot in a non-occluded LAA, which may increase the risk of
stroke. Occlusion of the LAA may prevent blood from entering the
LAA, thereby preventing blood from clotting in the LAA. Such
occlusion may therefore prevent blood clots from exiting the LAA
into the blood stream, such that the risk of stroke may be reduced
by occluding the LAA. Of course, there may be other purposes for
occluding the LAA, and there are a variety of other anatomical
structures that may be occluded. Due to the varying dimensions of
the LAA and other anatomical structures between individuals, it
will be appreciated that it may be desirable to provide occlusion
devices of varying dimensions and/or configurations to correspond
to the particular anatomical structure intended to be occluded or
for other purposes. While a variety of techniques and devices have
been used to treat anatomical structures such as the LAA, it is
believed that no one prior to the inventors has previously made or
used an invention as described below.
BRIEF DESCRIPTION OF DRAWINGS
[0003] It is believed the present invention will be better
understood from the following description of certain examples taken
in conjunction with the accompanying drawings, in which like
reference numerals identify the same elements and in which:
[0004] FIG. 1A depicts a cross-sectional view of an anatomical
structure, specifically a left atrial appendage and left
atrium;
[0005] FIG. 1B depicts a cross-sectional view of an exemplary use
of an occlusion device on the anatomical structure of FIG. 1A;
[0006] FIG. 2 depicts a front, cross-sectional view of an exemplary
occlusion device;
[0007] FIG. 3A depicts a plan view of an alternative occlusion
device; FIG. 38 depicts a plan view of the occlusion device of FIG.
3A including end caps;
[0008] FIG. 3C depicts a front view of the occlusion device of FIG.
38 in a closed configuration;
[0009] FIG. 3D depicts a front view of the occlusion device of FIG.
38 in an open configuration and an exemplary applier;
[0010] FIG. 4A depicts a perspective view of an alternative
occlusion device in an open configuration;
[0011] FIG. 4B depicts a front view of the occlusion device of FIG.
4A in an open configuration with a barb plate in a placement
configuration;
[0012] FIG. 4C depicts a front view of the occlusion device of FIG.
4A in an open configuration with a barb plate in a deployed
configuration;
[0013] FIG. 4D depicts a front view of the occlusion device of FIG.
4A in a closed configuration with a barb plate in a placement
configuration;
[0014] FIG. 4E depicts a front view of the occlusion device of FIG.
4A in a closed configuration with a barb plate in a deployed
configuration;
[0015] FIG. 5 depicts a perspective view of an alternative
occlusion device;
[0016] FIG. 6 depicts a perspective view of an alternative
occlusion device in an open configuration;
[0017] FIG. 7A depicts a perspective view of a sample of material
usable in an alternative method of occluding an anatomical
structure;
[0018] FIG. 7B depicts a cross-sectional view of the material of
FIG. 7A being drawn into an insertion device;
[0019] FIG. 7C depicts a cross-sectional view of the insertion
device of FIG. 7B filled with the material of FIG. 7A;
[0020] FIG. 7D depicts a perspective view of the insertion device
of FIG. 7B piercing an anatomical structure;
[0021] FIG. 7E depicts a cross-sectional view of the insertion
device of FIG. 7B depositing the material of FIG. 7A into the
anatomical structure of FIG. 7D;
[0022] FIG. 8A depicts a perspective view of an alternative
occlusion device; FIG. 8B depicts a cross-sectional view of the
occlusion device of FIG. 8A;
[0023] FIG. 9 depicts a perspective view of an alternative
occlusion device in an open configuration;
[0024] FIG. 10 depicts a partial cross-sectional view of the
occlusion device of FIG. 9 in an open configuration;
[0025] FIG. 11 depicts a perspective view of an alternative
occlusion device in an open configuration;
[0026] FIG. 12 depicts a cross-sectional view of the occlusion
device of FIG. 11 in a closed configuration engaging an anatomical
structure;
[0027] FIG. 13 depicts a perspective view of an alternative
occlusion device in an open configuration;
[0028] FIG. 14 depicts a cross-sectional view of the occlusion
device of FIG. 13 in a closed configuration engaging an anatomical
structure;
[0029] FIG. 15 depicts a perspective view of an alternative
occlusion device in a closed configuration;
[0030] FIG. 16 depicts a front view of the occlusion device of FIG.
15 in an open configuration;
[0031] FIG. 17A depicts a perspective view of an alternative
occlusion device in a closed configuration;
[0032] FIG. 17B depicts a front view of the occlusion device of
FIG. 17A in an open configuration;
[0033] FIG. 18A depicts a partial cross-sectional view of the hinge
of the occlusion device of FIG. 17A;
[0034] FIG. 18B depicts a partial cross-sectional view of an
alternative hinge of the occlusion device of FIG. 17A;
[0035] FIG. 18C depicts a partial cross-sectional view of an
alternative hinge of the occlusion device of FIG. 17A;
[0036] FIG. 19 depicts a perspective view of an alternative
occlusion device in an open configuration;
[0037] FIG. 20 depicts a front view of an alternative occlusion
device in a partially open configuration;
[0038] FIG. 21 depicts a partial perspective view of the locking
portion of the occlusion device of FIG. 20;
[0039] FIG. 22 depicts a front view of an alternative occlusion
device in an open configuration;
[0040] FIG. 23 depicts a partial perspective view of the locking
portion of the occlusion device of FIG. 22 in a closed
configuration;
[0041] FIG. 24 depicts a front view of an alternative occlusion
device; FIG. 25 depicts a bottom view of the occlusion device of
FIG. 24;
[0042] FIG. 26 depicts a perspective view of an alternative
occlusion device in an open configuration;
[0043] FIG. 27A depicts a front view of the occlusion device of
FIG. 26 in an open configuration;
[0044] FIG. 27B depicts a front view of the occlusion device of
FIG. 26 in a closed configuration;
[0045] FIG. 28 depicts a top view of an alternative occlusion
device;
[0046] FIG. 29 depicts a front view of the occlusion device of FIG.
28 in a partially open configuration;
[0047] FIG. 30A depicts a perspective view of an alternative
occlusion device in a closed configuration;
[0048] FIG. 30B depicts a cross-sectional view of the occlusion
device of FIG. 30A in a closed configuration;
[0049] FIG. 31 depicts a perspective view of an alternative
occlusion device in a closed configuration;
[0050] FIG. 32A depicts an end view of the occlusion device of FIG.
31 in a closed configuration;
[0051] FIG. 32B depicts an end view of the occlusion device of FIG.
31 in an open configuration;
[0052] FIG. 33 depicts a perspective view of an alternative
occlusion device in an open configuration;
[0053] FIG. 34 depicts a front view of the occlusion device of FIG.
33 engaging an anatomical structure as the device is transitioned
from an open configuration toward a closed configuration with an
exemplary applier;
[0054] FIG. 35 depicts a perspective view of an alternative method
of occluding an anatomical structure and exemplary components
associated with that method;
[0055] FIG. 36 depicts a perspective view of an alternative method
of occluding an anatomical structure and exemplary components
associated with that method;
[0056] FIG. 37 depicts a perspective view of an anatomical
structure occluded according to the method of FIG. 36;
[0057] FIG. 38 depicts a perspective view of an alternative
occlusion device in an open configuration;
[0058] FIG. 39 depicts a partial cross-sectional view of the
occlusion device of FIG. 38;
[0059] FIG. 40 depicts a perspective view of an
alternative-occlusion device in an open configuration;
[0060] FIG. 41 depicts a front view of the occlusion device of FIG.
40 in a deflated closed configuration;
[0061] FIG. 42 depicts a front view of the occlusion device of FIG.
40 in an inflated closed configuration;
[0062] FIG. 43 depicts a partial perspective view of an exemplary
applier; and
[0063] FIG. 44 depicts an alternative occlusion device with loops
configured to engage an applier.
DETAILED DESCRIPTION
[0064] The following description of certain examples of the
invention should not be used to limit the scope of the present
invention. Other examples, features, aspects, embodiments, and
advantages of the invention will become apparent to those skilled
in the art from the following description, which includes by way of
illustration, one of the best modes contemplated for carrying out
the invention. As will be realized, the invention is capable of
other different aspects, all without departing from the invention.
Accordingly, the drawings and descriptions should be regarded as
illustrative in nature and not restrictive.
[0065] It will be appreciated that many of the following
embodiments of an occlusion device may act as a clamp or clip. For
instance, as will be described in greater detail below, an
occlusion device may be secured to an anatomical structure. To the
extent that such an anatomical structure would otherwise permit
communication of fluid through the anatomical structure, the
clamping or other engagement of an occlusion device on the
anatomical structure may substantially prevent the communication of
fluid through, into, or out of the anatomical structure. Many of
the following embodiments of an occlusion device may therefore be
used to form an occlusion in the anatomical structure. It will be
appreciated, however, that an occlusion device need not necessarily
be used to form a complete occlusion in an anatomical structure,
and may be instead used simply to restrict or regulate the flow of
fluid through, into, or out of an anatomical structure. It will
also be appreciated that all of the following embodiments of an
occlusion device may have a variety of alternative uses other than
forming occlusions or restrictions in anatomical structures, and
their use need not even be limited to use with anatomical
structures. In addition, it will be appreciated that all of the
following embodiments of an occlusion device may be configured such
that the occlusion device is atraumatic with regard to the
anatomical structure being occluded, adjacent organs, and/or
adjacent tissue. Due to the varying dimensions of the LAA and other
anatomical structures between individuals, it will be appreciated
the overall dimensions or configuration of many of the following
embodiments of an occlusion device may be varied to accommodate
anatomical structures of different dimensions or for other
purposes.
[0066] Many of the following embodiments of an occlusion device may
include a sock configured to enshroud at least some components of
the occlusion device. A sock may comprise a knit, braided polyester
material. Of course, any other suitable materials may be used for a
sock, including but not limited to polyethylene. It will also be
appreciated that a sock is optional. Where an occlusion device is
positioned adjacent an anatomical structure, a sock may be
configured to provide friction and to facilitate the growth of scar
tissue. A sock may also be sutured to tissue to further secure an
occlusion device in place. The manner in which a sock may be
incorporated in many of the following embodiments of occlusion
devices and associated methods will become apparent to those of
ordinary skill in the art. Alternatively, components of an
occlusion device may be provided with a textured surface, or some
other device or configuration may be used to provide results
similar to those provided by a sock.
[0067] FIGS. 1A and 1B illustrate one exemplary use for an
occlusion device (10). In particular, FIG. 1A shows a view of the
left atrium (22) of a patient's heart (20). A left atrial appendage
(LAA) (24) is shown extending from the left atrium (22). With an
occlusion device (10) in an open configuration, the LAA (24) may be
passed through the opening in occlusion device (10), and the
occlusion device (10) positioned adjacent to the outside of the LAA
(24). With occlusion device (10) so positioned, an applier (not
shown) may release occlusion device (10), resulting in occlusion
device (10) transitioning toward a closed configuration. FIG. 1B
shows occlusion device (10) in a closed configuration. With
occlusion device (10) being positioned as shown in FIG. 1B in a
closed configuration, occlusion device (10) may be configured to
exert between approximately 2.5 pounds per square inch (psi) and
approximately 3 psi of pressure on LAA (24). Due to the
configuration of occlusion device (10) in this particular example,
such exerted pressure may be substantially uniform along the length
of occlusion device (10). Of course, occlusion device (10) may be
configured to exert any other suitable amount of pressure. In
addition, occlusion device (10) may be configured such that
pressure exerted by occlusion device (10) is not substantially
uniform.
[0068] In the present example, force or pressure exerted by the
closed occlusion device (10) results in occlusion device (10)
creating an occlusion of the LAA (24) by clamping the LAA (24),
thereby preventing blood from entering or leaving the LAA (24)
relative to the left atrium (22). Accordingly, those of ordinary
skill in the art will appreciate that occlusion device (10) may be
used in a remedial or prophylactic fashion, particularly for
reducing the risk of stroke by preventing the formation of blood
clots in the LAA (24).
[0069] If occlusion device (10) is left in the position and
configuration shown in FIG. 1B for a substantial period of time,
the LAA (24) may simply atrophy and wither away, and the occlusion
device (10) may essentially become engulfed in scar tissue. It will
be appreciated that the use of occlusion device (10) as illustrated
in FIGS. 1A and 18, and as described above, is merely exemplary,
and that an occlusion device (10) may be used in a variety of
different ways and with a variety of different anatomical
structures or other structures. It will also be appreciated that
any of the other occlusion devices described herein, or variations
thereof, may be used in a manner similar to that illustrated in
FIGS. 1A and 1B, and as described above, or in a variety of other
ways. Various other suitable uses will be apparent to those of
ordinary skill in the art.
[0070] FIG. 2 illustrates an exemplary occlusion device (50). As
shown, occlusion device (50) comprises a horizontal member (52) and
a base member (54). Horizontal member (52) and base member (54) are
generally curved in this example. It will be appreciated that such
curvature may compliment curvature of an anatomical structure to
which occlusion device (50) will be secured, or may otherwise
facilitate or optimize engagement of occlusion device (50) with an
anatomical structure. Alternatively, horizontal member (52) and/or
base member (54) may be generally straight or have any other
suitable configuration. In this example, base member (54) comprises
a horizontal portion (56) and vertical portions (58a and 58b)
formed in a substantially u-shaped configuration.
[0071] In the illustrated version, horizontal member (52) and base
member (54) include apertures (62a, 62b, 62c, 62d, 62e and 62f)
through which a cinching device (70) is threaded. In this example,
occlusion device (50) includes six apertures (62a-62f); however
occlusion device (50) may include any suitable number of apertures
in any suitable configuration. Cinching device (70) may comprise a
thread looped through apertures (62a-62f) such that a first end
(70a) and a second end (70b) extend through apertures (62a and
62b), respectively. Cinching device (70) may comprise a thread, a
string, a band, or any other suitable method or device.
[0072] With horizontal member (52) substantially vertically
separated from horizontal portion (56) of base member (54),
occlusion device (50) may be considered to be in an open
configuration. Alternatively, occlusion device (50) may be regarded
as being in a closed configuration when horizontal member (52) is
adjacent to horizontal portion (56), or where horizontal member
(52) and horizontal portion (56) are positioned such that the
vertical separation is relatively small. Occlusion device (50) may
be transitioned from an open configuration toward a closed
configuration by applying a substantially horizontal force to first
end (70a), substantially perpendicularly to vertical portion (58b),
while holding second end (70b) substantially stationary.
Alternatively, occlusion device (50) may be urged toward a closed
configuration by holding first end (70a) substantially stationary
while applying a substantially horizontal force to second end (70b)
substantially perpendicularly to vertical portion (58b). The
transition of occlusion device (50) from an open configuration to a
closed configuration may result in a positive lock. As used
throughout this specification, the term "positive lock" refers to a
one-way process of closing and locking a device, such that once the
device reaches a closed configuration, the device may not be
transitioned back to an open configuration without damaging the
device. Other variations in structure, use, and method of operation
of occlusion device (50) will be apparent to those of ordinary
skill in the art, and some embodiments permit unlocking.
[0073] Another exemplary occlusion device (100) is shown in FIGS.
3A-3D. In this version, occlusion device (100) comprises a clamping
member (110) and end caps (130). Clamping member (110) may comprise
a substantially flat spring material having a generally rectangular
cross-section. Clamping member may comprise Nitinol, plastic, or
any other suitable material. As shown in FIGS. 3A-3D, clamping
member (110) includes slots (112), a middle portion (122)
positioned between slots (112), and outer portions (120) positioned
between the respective slots (112) and the outer edges (115). In
this example, clamping member (110) includes two slots (112)
extending longitudinally along clamping member (110), however, any
suitable number or configuration of slots (112) may be used. As
shown in FIG. 38 end caps (130) are configured to be positioned on
opposite ends of clamping member (110) and include notches (132).
End caps (130) may comprise plastic, rubber, or any other suitable
material, and end caps (130) may be formed using a molding
processes or any other suitable device or method. As shown in FIG.
3C, when middle portion (122) and outer portions (120) form a
substantially flat, co-planar surface, occlusion device (100) may
be regarded as being in a fully closed configuration.
Alternatively, as shown in FIG. 3D, when middle portion (122) is
deflected in one direction and outer portions (120) are deflected
in an opposite direction, thereby creating an annular opening
(125), occlusion device (100) may be regarded as being in an open
configuration.
[0074] As shown in FIG. 3D, occlusion device (100) is transitioned
toward an open position utilizing an applier (150). Applier (150)
may include urging members (152a, 152b) configured to be received
by notches (132) in end caps (130). Once urging members (152a,
152b) are received by notches (132), urging members (152a, 152b)
may exert opposing, substantially horizontal forces inward, in the
directions of arrows (160a, 160b), respectively. As shown in FIG.
3D, the force may be sufficient to deflect outer portions (120) in
a first direction, while deflecting middle portion (122) in the
opposite direction, thereby transitioning occlusion device (100) to
an open configuration. When occlusion device (100) is in an open
configuration, an anatomical structure may be passed through the
annular opening (125). Once the anatomical structure and occlusion
device (100) are properly positioned, the substantially horizontal
force may be removed, allowing occlusion device (100) to return
toward the fully closed configuration, thereby occluding the
anatomical structure. Other variations in structure, use, and
method of operation of occlusion device (100) will be apparent to
those of ordinary skill in the art.
[0075] An alternative embodiment of an occlusion device (200) is
shown in FIGS. 4A-4E. In this version, occlusion device (200)
comprises an upper pressure plate (210); a lower pressure plate
(220), and a barb plate (230). Occlusion device (200) may comprise
plastic or any other suitable material, including, but not limited
to, bioabsorbable polymers. As shown in FIGS. 4A-4E, upper pressure
plate (210) includes an outer surface (212) and an inner surface
(214). Barb plate (230) may include an outer surface (232), an
inner surface (234), and barbs (236). Barbs (236) may project
substantially vertically downward from inner surface (234). In the
illustrated version, occlusion device (200) includes five barbs
(236) equally spaced longitudinally along barb plate (230).
However, occlusion device (200) may include any suitable number of
barbs (236) in any suitable configuration. Upper pressure plate
(210) may be configured such that barbs (236) may project through
apertures (not shown) in upper pressure plate (210). As shown in
FIGS. 4A-4E, lower pressure plate (220) includes an outer surface
(222) and an inner surface (224). Inner surface (224) may include a
plurality of receiving apertures (226). The number and
configuration of receiving apertures (226) may correspond to the
number and configuration of barbs (236). Lower pressure plate (220)
may include any suitable alternative number of receiving apertures
(226) in any suitable configuration.
[0076] Upper pressure plate (210), lower pressure plate (220), and
barb plate (230) are generally curved in this example. It will be
appreciated that such curvature may compliment curvature of an
anatomical structure to which occlusion device (200) will be
secured, or may otherwise facilitate or optimize engagement of
occlusion device (200) with an anatomical structure. Alternatively,
upper pressure plate (210), lower pressure plate (220) and barb
plate (230) may be generally straight or have any other suitable
configuration. In this example, upper pressure plate (210), lower
pressure plate (220) and barb plate (230) have corresponding
configurations, but that is not required. For example, upper
pressure plate (210) and lower pressure plate (220) may be curved
and barb plate (230) may be generally straight, or any other
suitable combination of configurations may be used.
[0077] As shown in FIG. 4B, with inner surface (234) of barb plate
(230) separated from outer surface (212) of upper pressure plate
(210), barb plate (230) may be regarded as being in a placement
configuration. As shown in FIG. 4C, when a substantially downward
force is applied to barb plate (230), such that inner surface (234)
of barb plate (230) is adjacent to outer surface (212) of upper
pressure plate (210), barb plate (230) may be regarded as being in
a deployed configuration. In an exemplary use of occlusion device
(200), an anatomical structure (not shown) may be positioned
between upper pressure plate (210) and lower pressure plate (220)
while barb plate (230) is in a placement configuration. Once the
anatomical structure is aligned, upper pressure plate (210) is
positioned adjacent to lower pressure plate (220), as shown in FIG.
40. The anatomical structure may be occluded by applying a
substantially downward force on barb plate (230), thereby
transitioning barb plate (230) into a deployed configuration, as
shown in FIG. 4E. Occlusion device (200) may be provided with a
feature that permits upper pressure plate (210) to be removably
attached to lower pressure plate (220) with barb plate (230) in a
placement configuration or with barb plate (230) in a deployed
configuration. For instance, a clasp, clip, or other device,
mechanism, or feature may be provided on upper pressure plate (210)
and/or lower pressure plate (220). In one embodiment, barbs (236)
and receiving apertures (226) are configured such that engagement
of barbs (236) within receiving apertures (226) provides a positive
lock, thereby securing barb plate (230) and upper pressure plate
(210) relative to lower pressure plate (220). It will be
appreciated that other methods of use may be suitable, such as, for
example, transitioning barb plate (230) into a deployed
configuration prior to positioning upper pressure plate (210)
adjacent to lower pressure plate (220). With upper pressure plate
(210) adjacent to lower pressure plate (220), the transition of
barb plate (230) from a placement configuration to a deployed
configuration may result in a positive lock. Other variations in
structure, use, and method of operation of occlusion device (200)
will be apparent to those of ordinary skill in the art.
[0078] Another exemplary occlusion device (300) is shown in FIG, 5.
In this version, occlusion device (300) comprises an upper portion
(310) attached to a lower portion (320). Upper portion (310) may
comprise an upper male member (312) inserted into an upper female
member (314). Lower portion (320) may comprise a lower male member
(322) inserted into a lower female member (324). As shown in FIG.
5, upper portion (310) is attached to lower portion (320) by
inserting lower male member (322) into upper female member (314)
and inserting upper male member (312) into lower female member
(324). In the illustrated version, such attachment creates an
opening (350) suitable for an anatomical structure. Male members
(312 and 322) and female members (314 and 324) may be configured to
operate as slide ratchets, thereby enabling the user to adjust the
size of opening (350) horizontally and/or vertically to accommodate
anatomical structures of varying lengths and/or thicknesses. By way
of example only, such ratcheting may permit the size of opening
(350) to only be reduced, without permitting it to be increased,
such that the ratcheting provides a positive lock. Occlusion device
(300) may comprise various metallic or nonmetallic materials or
both. A suitable nonmetallic material would be plastic, such as a
polycarbonate, but other suitable nonmetallic materials will be
apparent to one of ordinary skill in the art. Male members (312 and
322) and female members (314 and 324) may comprise the same
material or a combination of different materials.
[0079] Upper portion (310) and lower portion (320) are generally
curved in this example. It will be appreciated that such curvature
may compliment curvature of an anatomical structure to which
occlusion device (300) will be secured, or may otherwise facilitate
or optimize engagement of occlusion device (300) with an anatomical
structure. Alternatively, upper portion (310) and lower portion
(320) may be generally straight or have any other suitable
configuration. In this example, upper portion (310) and lower
portion (320) have corresponding configurations, but that is not
required. For example, upper portion (310) and/or lower portion
(320) may be generally straight or have any other suitable
configuration. Other variations in structure, use, and method of
operation of occlusion device (300) will be apparent to those of
ordinary skill in the art.
[0080] An alternative embodiment of an occlusion device (400) is
shown in FIG. 6. Occlusion device (400) comprises an upper clamping
portion (410) and a lower clamping portion (420). Upper clamping
portion (410) and lower clamping portion (420) may comprise a flat
spring material, such as, for example, Nitinol, having a generally
rectangular cross-section, however, other suitable materials and
cross-sections may be used. Upper clamping portion (410) and lower
clamping portion (420) may comprise the same material, but that is
not required. In the illustrated version, upper clamping portion
(410) includes a first hook (412) and a second hook (414) separated
by a gap (415) at each distal end of upper clamping portion (410).
As shown in FIG. 6, lower clamping portion (420) includes a rounded
end (422) and tab (424) at each distal end of lower clamping
portion (420). Upper clamping portion (410) may be attached to
lower clamping portion (420) by inserting tab (424) into gap (415),
such that tab (424) is positioned within first hook (412) and
second hook (414). In order to complete the attachment, the
attachment steps may be conducted on both distal ends of upper
clamping portion (410) and lower clamping portion (420). Occlusion
device (400) may be closed by forcing the center of upper clamping
portion (410) (or some other portion(s) of upper clamping portion)
toward lower clamping portion (420). Such movement of upper
clamping portion (410) may result in upper clamping portion (410)
"popping" or "snapping" toward lower clamping portion (420) after
upper clamping portion (410) is moved a particular distance toward
lower clamping portion (420). To the extent that a portion of an
anatomical structure is placed between upper clamping portion (410)
and lower clamping portion (420) at such time, the anatomical
structure may be crimped between the "popped"/"snapped" upper
clamping portion (410) and lower clamping portion (420). Other
variations in structure, use, and method of operation of occlusion
device (400) will be apparent to those of ordinary skill in the
art.
[0081] FIGS. 7A-7E depict a method and device for filling an
anatomical structure (520) with a material (500). In the
illustrated version, the method comprises drawing material (500)
into an insertion device (510), piercing the outer wall (522) of
anatomical structure (520) with the filled insertion device (510),
and injecting material (500) from insertion device (510) into an
interior cavity (525) of anatomical structure (520). Material (500)
may at least partially occupy interior cavity (525), thereby at
least partially occluding anatomical structure (520) (e.g., an
LAA). Material (500) may comprise any suitable biocompatible
material, including but not limited to an adhesive or collagen.
Insertion device (510) may comprise a hypodermic needle, a suitable
cannula, or any other suitable device. Other variations in
structure, use, and method of operation of the components depicted
in FIGS. 7A-7E will be apparent to those of ordinary skill in the
art.
[0082] Another exemplary occlusion device (600) is shown in FIGS.
8A-8S. In the illustrated version occlusion device (600) comprises
a bladder (610) connected to a fluid delivery system (620). Fluid
delivery system (620) may include a luer fitting (not shown) or any
other suitable device. As shown in FIGS. 8A-8S, bladder (610)
includes an upper portion (612) and a lower portion (614) which may
be separated to create a pocket (616) between upper portion (612)
and lower portion (614). The shape and size of bladder (610) may be
adapted to correspond to the anatomical structure being treated. An
anatomical structure may be inserted into pocket (616) with upper
portion (612) and (614) empty or partially filled. Fluid may be
delivered through fluid delivery system (620) into upper portion
(612) and/or lower portion (614) until the anatomical structure has
been sufficiently occluded by upper portion (612) and lower portion
(614). This embodiment may be particularly useful when attempting
to treat anatomical structures having irregular shapes and/or
thicknesses, or under other circumstances. Other variations in
structure, use, and method of operation of occlusion device (600)
will be apparent to those of ordinary skill in the art.
[0083] An alternative example of an occlusion device (700) is shown
in FIGS. 9-10. In the illustrated version, occlusion device (700)
has a unitary construction and comprises an upper clamping member
(710) connected to a lower clamping member (720) with a living
hinge (750). As used throughout this specification, the term
"living hinge" refers to a thin section of material configured to
connect two components and bend at the same time to allow the
components to move. A living hinge may comprise plastic, metal, or
any other suitable material. In this example, upper clamping member
(710) includes a locking tab (714) positioned on free end (712) of
upper clamping member (710). Lower clamping member (720) includes a
horizontal portion (722) and two curved portions (724 and 726).
Curved portion (724) may be positioned adjacent to living hinge
(750). In the illustrated version, curved portion (726) is
positioned at free end (728) of lower clamping member (720) and
includes a recess (730). Recess (730) may be configured to receive
locking tab (714). As shown in FIG. 10, a stop tab (732) is formed
in recess (730), such that when locking tab (714) is received by
recess (730), stop tab (732) engages locking tab (714). The
engagement of locking tab (714) may result in a positive lock
between upper clamping member (710) and lower clamping member
(720). Occlusion device (700) may comprise metal, a polymer, such
as, for example, polyglycolic acid, or any other suitable
material.
[0084] Upper clamping member (710) and lower clamping member (720)
are generally curved in this example. It will be appreciated that
such curvature may compliment curvature of an anatomical structure
to which occlusion device (700) will be secured, or may otherwise
facilitate or optimize engagement of occlusion device (700) with an
anatomical structure. Alternatively, upper clamping member (710)
and lower clamping member (720) may be generally straight or have
any other suitable configuration. In this example, upper clamping
member (710) and lower clamping member (720) have corresponding
configurations, but that is not required. For example, upper
clamping member (710) and/or lower clamping member (720) may be
generally straight or have any other suitable configuration. Other
variations in structure, use, and method of operation of occlusion
device (700) will be apparent to those of ordinary skill in the
art.
[0085] Another exemplary occlusion device (800) is shown in FIGS.
11-12. In the illustrated version, occlusion device (800) has a
unitary construction and comprises a hinge (810) connecting an
upper clamping portion (820) and a lower clamping portion (830).
Occlusion device (800) may comprise a metal, such as, for example,
Nitinol, or any other suitable material. In this example, lower
clamping portion (830) includes a free distal end (832), and upper
clamping portion includes a curved distal end (822) with a lip
(824). As shown in FIG. 11, occlusion device (800) is in an open
configuration, while FIG. 12 depicts occlusion device (800) in a
closed configuration. As shown in FIG. 12, when occlusion device
(800) is in a closed configuration, free distal end (832) engages
lip (824), thereby at least partially occluding an anatomical
structure (850) positioned between upper clamping portion (820) and
lower clamping portion (830).
[0086] Upper clamping portion (820) and lower clamping portion
(830) are generally curved in this example. It will be appreciated
that such curvature may compliment curvature of an anatomical
structure to which occlusion device (800) will be secured, or may
otherwise facilitate or optimize engagement of occlusion device
(800) with an anatomical structure. Alternatively, upper clamping
portion (820) and lower clamping portion (830) may be generally
straight or have any other suitable configuration. In this example,
upper clamping portion (820) and lower clamping portion (830) have
corresponding configurations, but that is not required. For
example, upper clamping portion (820) and/or lower clamping portion
(830) may be generally straight or have any other suitable
configuration. Other variations in structure, use, and method of
operation of occlusion device (800) will be apparent to those of
ordinary skill in the art.
[0087] An alternative embodiment of an occlusion device (900) is
shown in FIGS. 1314. In the illustrated version, occlusion device
(900) comprises an upper clamping member (910) attached to a lower
clamping member (920) with a hinge (930). Upper clamping member
(910) and lower clamping member (920) are generally curved in this
example. It will be appreciated that such curvature may compliment
curvature of an anatomical structure to which occlusion device
(900) will be secured, or may otherwise facilitate or optimize
engagement of occlusion device (900) with an anatomical structure.
Alternatively, upper clamping member (910) and lower clamping
member (920) may be generally straight or have any other suitable
configuration. In this example, upper clamping member (910) and
lower clamping member (920) have corresponding configurations, but
that is not required. For example, upper clamping member (910)
and/or lower clamping member (920) may be generally straight or
have any other suitable configuration.
[0088] FIG. 14 depicts occlusion device (900) in a closed
configuration with an anatomical structure (950) positioned between
upper clamping member (910) and lower clamping member (920). As
shown in FIGS. 13-14, upper clamping member (910) is configured to
have a generally concave cross-section, while lower clamping member
(920) is configured to have a corresponding generally convex
cross-section. However, other suitable cross-sections will be
apparent to one skilled in the art. Upper clamping member (910) and
lower clamping member (920) may comprise metal, plastic, such as,
for example, polyglycolic acid, or any other suitable material.
Additionally, upper clamping member (910) and lower clamping member
(920) may comprise the same material or they may comprise different
materials. In the illustrated version, hinge (930) comprises a pin.
However, hinge (930) may comprise a pin, a rod or any other
suitable device or method. Hinge (930) may include a spring (not
shown) configured to urge occlusion device (900) into a closed
configuration. Other variations in structure, use, and method of
operation of occlusion device (900) will be apparent to those of
ordinary skill in the art.
[0089] Another exemplary occlusion device (1000) is shown in FIGS.
15-16. In this example, occlusion device (1000) has a unitary
construction and comprises an upper clamping member (1010)
connected to a lower clamping member (1020) with an urging member
(1030). Upper clamping member (1010) and lower clamping member
(1020) are generally curved in this example. It will be appreciated
that such curvature may compliment curvature of an anatomical
structure to which occlusion device (1000) will be secured, or may
otherwise facilitate or optimize engagement of occlusion device
(1000) with an anatomical structure. Alternatively, upper clamping
member (1010) and lower clamping member (1020) may be generally
straight or have any other suitable configuration. In this example,
urging member (1030) is configured such that a constant spring
force is applied to upper clamping member (1010) and lower clamping
member (1020) urging occlusion device (1000) toward a closed
configuration, as shown in FIG. 15. In the illustrated version,
upper clamping member (1010) includes an upper notch (1015) and
lower clamping member (1020) includes a lower notch (1025). Upper
notch (1015) may be positioned along the width of upper clamping
member (1010) such that upper notch (1015) is positioned opposite
lower notch (1025) when occlusion device (1000) is in a closed
configuration. Upper notch (1015) and lower notch (1025) may be
configured to facilitate deployment or application to tissue with a
suitable tool (not shown). Of course, upper notch (1015) and lower
notch (1025) are not required, and other suitable structures,
configurations or devices may be included to facilitate deployment
or application. Other variations in structure, use, and method of
operation of occlusion device (1000) will be apparent to those of
ordinary skill in the art.
[0090] Further alternative embodiments of an occlusion device
(1100) are shown in FIGS. 17A-18C. In this example, occlusion
device (1100) comprises an upper clamping portion (1110) connected
to a lower clamping portion (1120) with a hinge (1130). FIG. 17A
depicts occlusion device (1100) in a closed configuration, while
occlusion device (1100) is shown in an open configuration in FIG.
17B. All of the components of occlusion device (1100) may be
enshrouded in a sock (1150), as described above. Sock (1150) may
comprise a knit, braided polyester material. Of course, any other
suitable materials may be used for sock (1150), including but not
limited to polyethylene. Upper clamping portion (1110) may comprise
a generally flat substantially rigid member (1112), while lower
clamping portion (1120) may comprise a generally curved
substantially flexible member (1122). In this example, lower
clamping portion (1120) also includes a first clasping member
(1124) and a second clasping member (1126) configured to releasably
engage upper clamping portion (1110) when occlusion device (1100)
is in a closed configuration.
[0091] In this version, hinge (1130) comprises a fabric hinge. As
illustrated in FIGS. 18A-18C, hinge (1130) may comprise an inner
hinge (1132), a fold back seam (1134), a double seam (1136) or any
other suitable seam or device. In the version illustrated in FIG.
18A, inner hinge (1132) comprises a flexible member (1133) with a
u-shaped configuration attached at one end to substantially rigid
member (1112) and attached at the opposite end to substantially
flexible member (1122). As shown in FIG. 18B, fold back seam (1134)
comprises the end portions of sock (1150) folded substantially
horizontally inward between upper clamping portion (1110) and lower
clamping portion (1120), and secured together using stitching,
adhesive, or any other suitable means. FIG. 18C depicts double seam
(1136) which comprises an inner portion (1150a) of sock (1150)
positioned adjacent to an outer portion (1150b) of sock (1150) in a
substantially vertical orientation. Double seam (1136) may further
comprise a stitching, or adhesive, or any other means for securing
inner portion (1150a) to outer portion (1150b). Other variations in
structure, use, and method of operation of occlusion device (1100)
will be apparent to those of ordinary skill in the art.
[0092] Another exemplary occlusion device (1200) is shown in FIG.
19. In this example, occlusion device (1200) has a unitary
construction and comprises an upper clamping member (1210)
connected to a lower clamping member (1220) by a curved member
(1230). Upper clamping member (1210) and lower clamping member
(1220) are generally curved in this example. It will be appreciated
that such curvature may compliment curvature of an anatomical
structure to which occlusion device (1200) will be secured, or may
otherwise facilitate or optimize engagement of occlusion device
(1200) with an anatomical structure. Alternatively, upper clamping
member (1210) and/or lower clamping member (1220) may be generally
straight or have any other suitable configuration. Occlusion device
(1200) may comprise plastic, such as, for example, polyglycolic
acid, or any other suitable material. In the illustrated version,
curved member (1230) follows a generally C-shape profile. However,
curved member (1230) may have any suitable profile or
configuration.
[0093] As shown in FIG. 19, upper clamping member (1210) includes a
head (1212). In this example, head (1212) includes an aperture
(1214) and a ratcheting member (1216). Lower clamping member (1220)
may include a strap (1222), which may include serrations (1224).
Serrations (1224) may occupy any suitable portion of strap (1222).
In this example, ratcheting member (1216) is configured to engage
serrations (1226) as strap (1224) is passed through aperture
(1214). Occlusion device (1200) may be transitioned from an open
configuration, as shown in FIG. 19, to a closed configuration (not
shown) by passing strap (1224) through aperture (1214), thereby
urging lower clamping portion (1220) toward upper clamping portion
(1210). The pressure applied to an anatomical structure positioned
between upper clamping member (1210) and lower clamping member
(1220) may be adjusted by passing a longer portion of strap (1224)
through aperture (1214). Once occlusion device (1200) is
transitioned to a closed configuration, the portion of strap (1224)
protruding beyond head (1212) may be severed from the portion of
strap (1224) engaged by ratcheting member (1216). The transition of
occlusion device (1200) from an open configuration to a closed
configuration may result in a positive lock. It will be appreciated
that head (1212) and strap (1222) may operate in a manner similar
to a conventional "zip tie." Other variations in structure, use,
and method of operation of occlusion device (1200) will be apparent
to those of ordinary skill in the art.
[0094] An alternative embodiment of an occlusion device (1300) is
shown in FIGS. 20-21. In this example, occlusion device (1300)
comprises a strap (1310) connected to a base member (1320). Base
member (1320) may include a support portion (1322) and a head
(1324). As shown in FIGS. 20-21, head (1324) includes an aperture
(1326) and a ratcheting member (not shown). In this example, strap
(1310) includes a fixed end (1312), a free end (1314), and
serrations (1316). Fixed end (1312) may be attached to support
portion (1322) using any suitable device or method. The ratcheting
member (not shown) may be configured to engage serrations (1316) as
free end (1314) is passed through aperture (1326). Head (1324) and
strap (1310) may therefore operate in a manner similar to a
conventional "zip tie." The pressure applied to an anatomical
structure positioned between strap (1310) and base member (1320)
may be adjusted by passing a longer portion of strap (1310) through
aperture (1326). Once occlusion device (1300) is transitioned to a
closed configuration, the portion of strap (1310) protruding beyond
head (1324) may be severed from the portion of strap (1310) engaged
by the ratcheting member (not shown). The transition of occlusion
device (1300) from an open configuration to a closed configuration
may result in a positive lock. Other variations in structure, use,
and method of operation of occlusion device (1300) will be apparent
to those of ordinary skill in the art.
[0095] Another exemplary occlusion device (1400) is shown in FIGS.
22-23. In this example, occlusion device (1400) includes a latch
(1410) hingedly connected to a base member (1420). Latch (1410) and
base member (1420) are generally curved in this example. It will be
appreciated that such curvature may compliment curvature of an
anatomical structure to which occlusion device (1400) will be
secured, or may otherwise facilitate or optimize engagement of
occlusion device (1400) with an anatomical structure.
Alternatively, latch (1410) and/or base member (1420) may be
generally straight or have any other suitable configuration.
[0096] In the illustrated version, latch (1410) includes side
members (1412), an end member (1414) and an opening (1416). As
shown in FIGS. 22-23, latch (1410) has a generally u-shaped
configuration. However, latch (1410) may have any suitable
configuration. Base member (1420) may include a support portion
(1422) and a latching portion (1424). As shown in FIG. 22, support
portion (1422) is configured to hingedly attach latch (1410) and
base member (1420). Latching portion (1424) may comprise a tab
(1426) with ridges (1428) included on a front face (1427) of tab
(1426). Ridges (1428) also extend along a portion of each side of
tab (1426) in this example. As shown in FIGS. 22-23, tab (1426) has
a generally curved configuration, however, tab (1426) may be
generally curved, rectangular, triangular, or have any other
suitable configuration. In this version, tab (1426) includes a set
of four ridges (1428); however any suitable number of ridges may be
used.
[0097] FIG. 22 depicts occlusion device (1400) in an open
configuration, while occlusion device (1400) is shown in a closed
configuration in FIG. 23. Occlusion device (1400) may be
transitioned toward a closed configuration by partially or
completely passing tab (1426) through opening (1416). In this
example, ridges (1428) are configured to engage side members (1412)
as tab (1426) is passed through opening (1416). Ridges (1428) may
provide a range of locking positions configured to allow the user
to vary the amount of pressure applied by occlusion device (1400).
Other variations in structure, use, and method of operation of
occlusion device (1400) will be apparent to those of ordinary skill
in the art.
[0098] An alternative embodiment of an occlusion device (1500) is
shown in FIGS. 24-25. In this version, occlusion device (1500)
comprises an upper clamping member (1510), a lower clamping member
(1520) and a locking mechanism (1530). As shown, lower clamping
member (1520) includes a fastener (1522) and a locking member
(1524) comprising an aperture (1526) and a ratcheting member (not
shown). In this example, locking mechanism (1530) comprises a strap
(1532) which includes a fixed end (1534), a free end (1536),
serrations (1538) and an eyelet (1540). Strap (1532) may be
sufficiently rigid to maintain a c-shaped profile between upper
clamping member (1510) and lower clamping member (1520), as shown
in FIG. 24. Serrations (1538) may occupy any suitable portion of
strap (1532). Eyelet (1540) may be configured to facilitate
grasping of strap (1532). As shown in FIGS. 24-25, fixed end (1534)
is attached to lower clamping member (1520) by a fastener (1522)
and looped around upper clamping member (1510) such that free end
(1536) may be passed through locking member (1524). A ratcheting
member (not shown) may be configured to engage serrations (1538) as
strap (1532) is passed through aperture (1526). Locking member
(1524) and strap (1532) may thus operate in a manner similar to a
conventional "zip tie." Occlusion device (1500) may be transitioned
from an open configuration, as shown in FIG. 24, to a closed
configuration (not shown) by grasping eyelet (1540) and passing
strap (1532) through aperture (1526), thereby urging lower clamping
member (1520) toward upper clamping member (1510). In an
alternative version of this embodiment, the locking mechanism may
comprise resilient urging members configured to connect the upper
clamping member and lower clamping member while urging the upper
clamping member and lower clamping member together. Other
variations in structure, use, and method of operation of occlusion
device (1500) will be apparent to those of ordinary skill in the
art.
[0099] Another exemplary occlusion device (1600) is shown in FIGS.
26-27B. In this example, occlusion device (1600) comprises a
support member (1610) and a flexible looped clamping member (1620).
In the illustrated version, flexible clamping member (1620)
comprises a suture. However, clamping member (1620) may comprise a
suture, a thread, a strand, an absorbable fiber, a monofilament or
any other suitable device. As shown in FIGS. 26-27B, flexible
clamping member (1620) is looped around support member (1610), and
flexible clamping member (1620) includes a looped portion (1622), a
knot (1624), and an activation end (1626). Support member (1610)
may include a clamping surface (1612), a lower surface (1614), a
looping notch (1616), a fastening aperture (not shown), and
alignment members (1618). In this version, looping notch (1616) and
the fastening aperture (not shown) are located on opposite ends of
support member (1610), and alignment members (1618) project outward
from lower surface (1614). Alignment members (1618) each include an
aperture (not shown). Support member (1610) is generally curved in
this example. It will be appreciated that such curvature may
compliment curvature of an anatomical structure to which occlusion
device (1600) will be secured, or may otherwise facilitate or
optimize engagement of occlusion device (1600) with an anatomical
structure. Alternatively, support member (1610) may be generally
straight or have any other suitable configuration.
[0100] FIGS. 26-27 A depict occlusion device (1600) in an open
configuration, while FIG. 278 shows occlusion device (1600) in a
closed configuration. Activation end (1626) of flexible clamping
member (1620) may be passed through the fastening aperture (not
shown), threaded along lower surface (1614) through the apertures
(not shown) in alignment members (1618), passed through looping
notch (1616), looped above clamping surface (1612), tied in a knot
(1624) and passed through the fastening aperture (not shown).
Occlusion device (1600) may be transitioned from an open
configuration to a closed configuration by exerting a force on
activation end (1626) in a direction generally away from support
member (1610). In this example, knot (1624) is configured to allow
activation end to be extended, thereby urging looped portion (1622)
toward clamping surface (1612). The desired anatomical structure
(not shown) may be occluded by positioning the anatomical structure
between looped portion (1622) and clamping surface (1612) and
transitioning occlusion device (1600) from an open configuration
toward a closed configuration. To maintain a closed configuration,
occlusion device (1600) may comprise a feature configured to permit
movement of clamping member (1620) in only one direction.
Alternatively, clamping member (1620) may be tied off, knotted, or
otherwise manipulated to maintain a closed configuration. Other
suitable techniques and features for maintaining a closed
configuration will be apparent to those of ordinary skill in the
art. Furthermore, other variations in structure, use, and method of
operation of occlusion device (1600) will be apparent to those of
ordinary skill in the art.
[0101] An alternative embodiment of an occlusion device (1700) is
shown in FIGS. 28-29. In the illustrated version, occlusion device
(1700) comprises a clamping structure (1710) and an urging device
(1720). In this example, urging device (1720) is looped completely
around the outer surface of clamping structure (1710), and urging
device (1720) provides a constant inward force urging occlusion
device (1700) toward a closed configuration (not shown). Urging
device (1720) may comprise a rubber band, a resilient thread, an
elastic loop, or any other suitable device. Clamping structure
(1710) may comprise an upper clamping portion (1712), a lower
clamping portion (1714) and a connecting portion (1716). As shown
in FIGS. 28-29, upper clamping portion (1712) and lower clamping
portion (1714) each include a substantially flat contact surface
(1713) and application structures (1715) positioned adjacent the
distal ends (1718) opposite connecting portion (1716). In this
version, connecting portion (1716) has a generally c-shaped
profile, however, any suitable configuration may be used.
Application structures (1715) may be configured such that an
applier (not shown) may engage application structures (1715) to
facilitate manipulation of occlusion device (1700). Application
structures (1715) may comprise apertures, indentations, recesses,
protuberances, or any other suitable devices or structures. Of
course, application structures (1715) may also be omitted. Other
variations in structure, use, and method of operation of occlusion
device (1700) will be apparent to those of ordinary skill in the
art.
[0102] Another exemplary occlusion device (1800) is shown in FIGS.
30A-30B. In this example, occlusion device (1800) comprises a
clamping plate (1810) and a base member (1820). Clamping plate
(1810) may be generally flat with a slightly curved edge (1812) and
may include attachment tabs (1814). Base member (1820) may comprise
a substantially flat central portion (1822) and side portions
(1824). In this example, side portions (1824) are oriented
substantially perpendicularly to central portion (1822) and
positioned on opposing edges of central portion (1822). Side
portions (1824) may include attachment apertures (1826) and
ratcheting teeth (1828). In the illustrated version, attachment
tabs (1814) are inserted into attachment apertures (1826), such
that clamping plate (1810) is rotatably connected to base member
(1820). Clamping plate (1810) may rotate about a central axis
extending generally through the center of attachment apertures
(1826).
[0103] As shown in FIGS. 30A-30B, ratcheting teeth (1828) are
configured to engage clamping plate (1810) as edge (1812) is
rotated toward central portion (1822). Side portions (1824) may
include a series of ratcheting teeth (1828) configured to provide
multiple closed configurations, thereby enabling the user to vary
the pressure applied to an anatomical structure positioned between
clamping plate (1810) and central portion (1822). In the
illustrated version, each side portion (1824) includes two
ratcheting teeth (1828). However, any suitable number of ratcheting
teeth (1828) may be used. The configuration and number of
ratcheting teeth (1828) included on one side portion (1824) may
correspond to the configuration and number of ratcheting teeth
(1828) included on the opposing side portion (1824), but this is
not required. Occlusion device (1800) may be regarded as being in
an open configuration with clamping plate (1810) disengaged from
ratcheting teeth (1828). With clamping plate (1810) engaged by a
pair of intermediate ratcheting teeth (1828), occlusion device
(1800) may be regarded as being in an intermediate clamping
configuration. As shown in FIGS. 30A-30B, with clamping plate
(1810) positioned between central portion (1822) and the adjacent
pair of ratcheting teeth (1828a), occlusion device (1800) may be
regarded as being in a closed configuration. Ratcheting teeth
(1828) may be configured to substantially impede or completely
prevent rotation of clamping plate (1810) toward an open
configuration after ratcheting teeth (1828) engage clamping plate
(1810). Other variations in structure, use, and method of operation
of occlusion device (1800) will be apparent to those of ordinary
skill in the art.
[0104] An alternative embodiment of an occlusion device (1900) is
shown in FIGS. 31-32B. Occlusion device (1900) comprises a clamping
member (1910) and a base member (1920). Clamping member (1910) may
comprise a rotatable cam element, as shown in FIGS. 31-32B,
including an elongated portion (1912) and a contact surface (1914).
In particular, clamping member (1910) may be configured as an
over-center cam. However, any suitable device or configuration may
be used. In this example, base member (1920) includes a horizontal
portion (1922) and side portions (1924a and 1924b). Base member
(1920) may have a unitary configuration, but this is not required.
In the illustrated version, clamping member (1910) is rotatably
connected to side portions (1924a and 1924b) such that clamping
member (1910) may be transitioned between a closed configuration,
as shown in FIG. 32A, and an open configuration, as shown in FIG.
32B. Clamping member (1910) may be connected to side portions
(1924a and 1924b) with a rod, tabs, or any other suitable
device.
[0105] Occlusion device (1900) may be transitioned from an open
configuration toward a closed configuration by rotating clamping
member (1910) such that contact surface (1914) transitions toward
horizontal portion (1922). Transitioning may be facilitated by an
applier (not shown) configured to engage elongated portion (1912).
Once occlusion device (1900) is transitioned toward a closed
configuration with an appendage (not shown) positioned between
clamping member (1910) and horizontal portion (1922), the appendage
may apply a generally vertical horizontal force along the rear
portion (1914a) of contact surface (1914), thereby securing
occlusion device (1900) in a closed configuration. Other variations
in structure, use, and method of operation of occlusion device
(1900) will be apparent to those of ordinary skill in the art.
[0106] Another exemplary occlusion device (2000) is shown in FIGS.
33-34. In this example, occlusion device (2000) has a unitary
construction and comprises an upper portion (2010), a barbed member
(2020) and a connecting portion (2030). Occlusion device (2000) may
comprise a substantially flexible material, such as, for example,
polyglycolic acid, or any other suitable material. In this version,
barbed member (2020) includes an outer surface (2021), an inner
surface (2022), guide members (2024), and barbs (2026). In the
illustrated version, barbed member (2020) includes fourteen barbs
(2026) projecting outward from inner surface (2022) aligned along
the longitudinal axis of barbed member (2020). However, barbed
member (2020) may include any suitable number of barbs (2026)
arranged in any suitable configuration. In this example, barbs
(2026) comprise conical protuberances. However, barbs (2026) may
comprise any suitable configuration, including, but not limited to,
cylindrical posts and cylindrical posts with conical tips. Upper
member (2010) includes an outer surface (2011) and attachment
apertures (2012). As shown in FIG. 33, the number and configuration
of attachment apertures (2012) corresponds to the number and
configuration of barbs (2026). However, upper member (2010) may
include any suitable number of attachment apertures (2012) in any
suitable configuration. In this version, connecting portion (2030)
attaches upper member (2010) to barbed member (2020), and
connecting portion (2030) comprises a flexible hinge.
[0107] FIG. 34 depicts an applier (2050) facilitating the
transition of occlusion device (2000) from an open configuration,
as shown in FIG. 33, toward a closed configuration. Applier (2050)
may include an upper jaw (2052), a lower jaw (2054), and a grasping
member (2060) projecting from a main body (2051). In the
illustrated version, upper jaw (2052) and lower jaw (2054) are
connected by a hinge (2056), and each jaw includes a roller (2058a
and 2058b). In this example, roller (2058a) is positioned adjacent
to the distal end of upper jaw (2052) and roller (2058b) is
positioned adjacent to the distal end of lower jaw (2054). Rollers
(2058a and 2058b) are configured to travel along the outer surface
(2011) of upper member (2010) and the outer surface (2021) of
barbed member (2020). Grasping member (2060) includes a grasping
tip (2062) configured to be inserted into connecting portion (2030)
of occlusion device (2000).
[0108] As shown in FIG. 34, an anatomical structure (2070) may be
positioned between upper member (2010) and barbed member (2020)
when occlusion device (2000) is in an open configuration. Applier
(2050) may be positioned such that grasping tip (2062) is inserted
into connecting portion (2030) and rollers (2058a and 2058b)
contact outer surface (2011) of upper member (2010) and outer
surface (2021) of barbed member (2020) respectively. In order to
transition occlusion device (2000) from an open configuration to a
closed configuration, grasping member (2060) is drawn in a
substantially horizontal direction, while upper jaw (2052) and
lower jaw (2054) are urged in the opposite substantially horizontal
direction. As occlusion device (2000) passes between rollers (2058a
and 2058b) upper member (2010) and barbed member (2020) are drawn
together, thereby urging barbs (2026) to protrude, at least
partially, into attachment apertures (2012). Barbs (2026) may
pierce anatomical structure (2070), but that is not required. Once
a suitable length of occlusion device (2000) has passed through
rollers (2058a and 2058b) occlusion device (2000) may be regarded
as being in a closed configuration. Other variations in structure,
use, and method of operation of occlusion device (2000) will be
apparent to those of ordinary skill in the art.
[0109] FIG. 35 depicts an alternative device and method of
occluding an anatomical structure (2110). In the illustrated
example, anatomical structure (2110) comprises the left atrial
appendage. However, anatomical structure (2110) may comprise any
suitable anatomical structure. The illustrated method includes a
patch (2120), sutures (2130) and a deployment device (2140). Patch
(2120) is configured to cover a portion of the upper surface (2111)
of anatomical structure (2110). As shown in FIG. 35, patch (2120)
covers the portion of anatomical structure (2010) that the user
intends to suture. Patch (2120) may comprise a natural material, a
synthetic material, such as, for example, polyester, or any other
suitable material. In this example, a series of sutures (2130) is
applied to the portion of anatomical structure (2110) covered by
patch (2120), thereby, at least temporarily, securing patch (2120)
to anatomical structure (2110). Sutures (2130) may be applied with
a deployment device (2140). In this example, deployment device
(2140) is an automated suturing device. However, sutures (2130) may
be applied manually with a suturing needle or by any other suitable
device or method. Sutures (2130) may be applied using any suitable
technique, including, but not limited to, continuous stitch,
interrupted stitch, mattress stitch, and blanket stitch. In
addition, sutures (2130) may comprise a nonabsorbable synthetic
material, such as, for example, nylon or polypropylene, an
absorbable synthetic material, such as, for example, polyglycolic
acid, a natural material, such as, for example, silk, or any other
suitable material. Patch (2120) may provide structural support for
sutures (2130) or serve any other purpose. Other variations in
structure, use, and method of operation of patch (2120) and/or
sutures (2130) will be apparent to those of ordinary skill in the
art.
[0110] An alternative method and associated device for occluding an
anatomical structure (2210) are depicted in FIGS. 36-37. Similar to
the method and device illustrated in FIG. 34, as shown in FIGS.
36-37, anatomical structure (2210) comprises the left atrial
appendage. However, anatomical structure (2210) may comprise any
suitable anatomical structure. The illustrated method includes a
deployment device (2220) and sutures (2230). Deployment device
(2220) may include a front face (2221), an upper grasping portion
(2222), a lower grasping portion (2224), and a spiral suturing
member (2226). In this example, with anatomical structure (2210)
positioned between upper grasping portion (2222) and lower grasping
portion (2224), spiral suturing member (2226) extends from front
face (2221) and penetrates into anatomical structure (2210). Spiral
suturing member (2226) rotates as it passes through anatomical
structure (2210), thereby applying sutures (2230) in a corkscrew or
spiral configuration. As shown in FIGS. 36-37, sutures (2230) are
applied along the entire width of anatomical structure (2210), but
that is not required. Sutures (2230) may be applied to any suitable
portion of anatomical structure (2210). Sutures (2230) may comprise
an absorbable synthetic material, such as polyglycolic acid, or any
other suitable material. The illustrated method and device may be
particularly useful for anatomical structures with varying tissue
thickness, and the illustrated method and device may help reduce or
eliminate; trauma to adjacent tissue. Other variations in
structure, use, and method of operation of deployment device (2220)
will be apparent to those of ordinary skill in the art.
[0111] Another exemplary occlusion device (2300) is shown in FIGS.
38-39. In this version, occlusion device (2300) includes an upper
clamping portion (2310), a lower clamping portion (2320), a hinge
(2330), and a fluid delivery system (2340). As shown in FIGS.
38-39, upper clamping portion (2310), lower clamping portion
(2320), and hinge (2330) are enshrouded in a sock (2350). Sock
(2350) may comprise a knit, braided polyester material. Of course,
any other suitable materials may be used for sock (2350), including
but not limited to polyethylene. In this example, hinge (2330)
comprises a fabric hinge formed by sock (2350). Upper clamping
portion (2310) may comprise an insert (2312) enshrouded in sock
(2350) Insert (2312) may comprise a polymer, such as, for example,
polyglycolic acid, or any other suitable material. Insert (2312)
may be substantially flat, substantially curved to correspond to
the curvature of a particular anatomical structure, or have any
other suitable configuration. Insert (2312) may be substantially
rigid, but that is not required.
[0112] As shown in FIGS. 38-39, lower clamping portion (2320)
comprises insert (2322), a bladder (2324), an inflation aperture
(2325), a first clasping member (2326), and a second clasping
member (2328), all of which are enshrouded in sock (2350). Insert
(2322) may comprise a polymer, such as, for example, polyglycolic
acid, or any other suitable material. Insert (2322) may be
substantially flat, substantially curved to correspond to the
curvature of a particular anatomical structure, or have any other
suitable configuration. Insert (2322) may be substantially rigid,
but that is not required. In the illustrated version, insert (2322)
includes an upper surface (2323). Insert (2322) may be configured
to allow bladder (2324) to rest adjacent to upper surface (2323).
Bladder (2324) may be configured to expand and contract as fluid is
delivered into and out of bladder (2324). In this example, first
clasping member (2326) and second clasping member (2328) are
configured to releasably engage upper clamping portion (2310) when
occlusion device (2300) is in a closed configuration. Fluid may be
delivered to bladder (2324) when occlusion device (2300) is in an
open configuration or when occlusion device (2300) is in a closed
configuration.
[0113] As shown in FIG. 38, fluid delivery system (2340) includes a
delivery tube (2342) and a tube clip (2344). Fluid delivery system
(2340) may include a luer fitting (not shown) configured to enable
saline to be delivered to bladder (2324), but that is not required.
In this example, delivery tube (2342) is passed through inflation
aperture (2325) and connected to bladder (2324). Delivery tube
(2342) may be configured to allow bladder (2324) to be inflated or
deflated. With occlusion device (2300) in a closed configuration,
the pressure applied to an appendage positioned between upper
clamping portion (2310) and lower clamping portion (2320) may be
varied by inflating or deflating bladder (2324). Once the desired
level of inflation is reached, tube clip (2344) may be applied to
delivery tube (2342) to temporarily seal delivery tube (2342) and
maintain the desired level of inflation. In this version, tube clip
(2344) comprises a u-shaped configuration, but any suitable
configuration may be used. Tube clip (2344) may comprise a polymer,
such as, for example, polyglycolic acid, or any other suitable
material. Other variations in structure, use, and method of
operation of occlusion device (2300) will be apparent to those of
ordinary skill in the art.
[0114] An alternative embodiment of an occlusion device (2400) is
shown in FIGS. 40-42. In this example, occlusion device (2400)
comprises an upper clamping portion (2410) connected to a lower
clamping portion (2420) with a hinge (2430), and a fluid delivery
system (2450). Upper clamping portion (2410) and lower clamping
portion (2420) are generally curved in this example. It will be
appreciated that such curvature may compliment curvature of an
anatomical structure to which occlusion device (2400) will be
secured, or may otherwise facilitate or optimize engagement of
occlusion device (2400) with an anatomical structure.
Alternatively, upper clamping portion (2410) and lower clamping
portion (2420) may be generally straight or have any other suitable
configuration. Upper clamping portion (2410) includes an upper
shell (2412) and an upper bladder (2414). In this version, upper
shell (2412) includes a cavity configured to house upper bladder
(2414), an attachment tab (2416) positioned on a distal end and a
proximal end attached to hinge (2430). With upper bladder (2414)
positioned in the cavity, a lower surface (2415) of upper bladder
(2414) is exposed. Similarly, lower clamping portion (2420)
includes a lower shell (2422) and a lower bladder (2424). In this
version, lower shell (2422) includes a cavity configured to house
lower bladder (2424), an attachment member (2426) positioned on a
distal end and a proximal end attached to hinge (2430). With lower
bladder (2424) positioned in the cavity, an upper surface (2425) of
lower bladder (2424) is exposed. In this example, attachment member
(2426) includes a slot (2427) configured to releasably engage
attachment tab (2416) when occlusion device (2400) is in a closed
configuration, as shown in FIGS. 41-42.
[0115] As shown in FIGS. 40-42, fluid delivery system (2450)
comprises a delivery tube (2452) and a connection fixture (2454).
Connection fixture (2454) may comprise a luer fitting or any
suitable type of fitting. Fluid delivery system (2450) may deliver
any suitable type of fluid, including, but not limited to, a gas,
water, saline, or any other suitable fluid. In the illustrated
example, delivery tube (2452) is connected to hinge (2430). Hinge
(2430) may comprise a passageway through which fluid may pass from
delivery tube (2452) through upper shell (2412) into upper bladder
(2414) and through lower shell (2422) into lower bladder (2424).
Alternatively, delivery tube (2452) may be connected directly to
upper bladder (2414) and lower bladder (2424), or have any other
suitable connection or configuration. In another embodiment (not
shown), each bladder (2414 and 2424) is associated with a
respective dedicated delivery tube.
[0116] The inflation level of upper bladder (2414) and/or lower
bladder (2424) may be increased or decreased with occlusion device
(2400) in an open configuration, as shown in FIG. 40, or closed
configuration, as shown in FIGS. 41-42. As shown in FIG. 41, upper
bladder (2414) and lower bladder (2424) are deflated or only
partially inflated while occlusion device (2400) is in a closed
configuration. FIG. 42 depicts occlusion device (2400) in a closed
configuration with upper bladder (2414) and lower bladder (2424)
both fully inflated, such that inner surface (2415) abuts inner
surface (2425). The pressure applied to an appendage positioned
between inner surface (2415) and inner surface (2425) may be varied
by adjusting the inflation level of upper bladder (2414) and/or
lower bladder (2424). Other variations in structure, use, and
method of operation of occlusion device (2400) will be apparent to
those of ordinary skill in the art.
[0117] FIG. 43 depicts an alternative version of an applier
discussed in International Application Serial No.
PCT/US2006/027553, published as WO 2007/009099, filed on Jul. 14,
2006, the disclosure of which has been incorporated by reference
herein. As shown in FIG. 43, applier (2500) includes an alternative
grasping portion (2510). As shown, grasping portion (2510) is
similar to the grasping portion described in International
Application Serial No. PCT/US2006/027553, except that lower rod
(2520) of grasping portion (2510) has a telescoping portion (2522).
Accordingly, by extending or retracting telescoping portion (2522),
a user may change the effective length of lower rod (2522). For
instance, such a grasping portion (2510) may be useful to
accommodate occlusion devices of various lengths. By way of example
only, an occlusion device may be approximately 25 mm long, or of
any other length. It will also be appreciated that grasping portion
(2510) need not necessarily be used to accommodate occlusion
devices of varying lengths, and that the non-telescoping grasping
portion described in International Application Serial No.
PCT/US2006/027553 may also accommodate occlusion devices of varying
lengths. In yet another embodiment (not depicted), upper rod (2530)
also comprises a telescoping portion (not shown). Alternatively,
upper rod (2530) may have a telescoping portion with lower rod
(2520) lacking a telescoping portion. In still another embodiment,
upper rod (2530) and/or lower rod (2520) may be configured such
that their effective lengths may be varied using any suitable
alternative to a telescoping portion. Other suitable variations
will be apparent to those of ordinary skill in the art.
[0118] FIG. 44 depicts an alternative version of an occlusion
device discussed in International Application Serial No.
PCT/US2006/027553, published as WO 2007/009099, filed on Jul. 14,
2006, the disclosure of which has been incorporated by reference
herein. It will be appreciated that an occlusion device (2600) may
include one or more features configured to facilitate manipulation
of the occlusion device (2600) by an applier. One example of such a
feature is shown in FIG. 44. In particular, occlusion device (2600)
is shown with a plurality of loops (2690). Loops (2690) are
positioned on horizontal members (2610), and the spacing of loops
(2690) is configured to correspond with the spacing of prongs on an
applier. In this embodiment, for engagement of occlusion device
(2600) with an applier, the prongs need not necessarily be inserted
between horizontal members (2610); but can instead be inserted
through corresponding loops (2690). With the prongs inserted in
loops (2690), the handle portion of the applier may be squeezed by
the user to bring the handle portion to a closed configuration,
thereby bringing the grasping portion and occlusion device (2600)
to an open configuration. In other words, the prongs may pull
horizontal members (2610) apart by pulling on loops (2690). Loops
(2690) may be provided as a part of a sock (2640) or may be
provided separately (e.g., even in embodiments lacking a sock
(2640)). Of course, as with any other component described herein,
loops (2690) are merely optional, and loops (2690) may be subject
to any other uses, modifications, substitutions, or
supplements.
[0119] Still further embodiments are described in the appendix
hereto.
[0120] Having shown and described various embodiments of the
present invention, further adaptations of the methods and systems
described herein may be accomplished by appropriate modifications
by one of ordinary skill in the art without departing from the
scope of the present invention. Several of such potential
modifications have been mentioned, and others will be apparent to
those skilled in the art. For instance, the examples, embodiments,
geometries, materials, dimensions, ratios, steps, and the like
discussed above are illustrative and are not required. Accordingly,
the scope of the present invention should be considered in terms of
the following claims and is understood not to be limited to the
details of structure and operation shown and described in the
specification and drawings.
* * * * *